Brand Name | GRIPPER PLUS NEEDLE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL |
st. paul MN |
|
Manufacturer Contact |
pete
hirte
|
1265 grey fox rd. |
st. paul, MN 55112
|
6516287384
|
|
MDR Report Key | 4207367 |
MDR Text Key | 4983830 |
Report Number | 2183502-2014-00565 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K021999 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
08/07/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/07/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 21-2770 |
Device Catalogue Number | 21-2770 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 07/22/2014 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/07/2014 |
Event Location |
Hospital
|
Date Manufacturer Received | 07/18/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | PORT-A-CATH |
|
|